The present invention is directed to a treatment for bacterial vaginosis (BV). The exact etiology of BV is unclear although it appears to result from an overgrowth of organisms in the vaginal flora. Although generally a mild condition, BV is distressing to the patient because of the unpleasant vaginal odor and discharge. In addition, it is epidemiologically linked to several urogenital diseases. Clindamycin vaginal cream (CVC) 100 mg per day for 7 days is a standard treatment for BV. It has recently been demonstrated that a 3-day treatment course of CVC is as effective as a 7-day course. However, even with a 3-day treatment, the use of creams is considered to be inconvenient. A vaginal ovule (suppository) formulation containing clindamycin would offer patients an alternative, more convenient dosage form. Therefore, the development of a vaginal suppository having at least the same efficacy as CVC was undertaken. As a result of this development effort, it was discovered that Hard Fat NF suppository bases significantly increased the storage stability of clindamycin.
We have developed a highly storage-stable composition for vaginal administration of clindamycin which comprises a vaginal suppository containing an antimicrobially effective amount of clindamycin dispersed in a Hard Fat suppository base, preferably Hard Hat NF grade. Hard Fat bases are a mixture of glyceride esters of higher saturated fatty acids. The Hard Fat NF suppository bases provide a clindamycin product having increased stability over the CVC formulation while providing equivalent efficacy against BV.